AU2018335259A1 - High dosage valbenazine formulation and compositions, methods, and kits related thereto - Google Patents
High dosage valbenazine formulation and compositions, methods, and kits related thereto Download PDFInfo
- Publication number
- AU2018335259A1 AU2018335259A1 AU2018335259A AU2018335259A AU2018335259A1 AU 2018335259 A1 AU2018335259 A1 AU 2018335259A1 AU 2018335259 A AU2018335259 A AU 2018335259A AU 2018335259 A AU2018335259 A AU 2018335259A AU 2018335259 A1 AU2018335259 A1 AU 2018335259A1
- Authority
- AU
- Australia
- Prior art keywords
- valbenazine
- formulation
- compositions
- methods
- high dosage
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Pending
Links
- 239000000203 mixture Substances 0.000 title abstract 3
- GEJDGVNQKABXKG-CFKGEZKQSA-N [(2r,3r,11br)-9,10-dimethoxy-3-(2-methylpropyl)-2,3,4,6,7,11b-hexahydro-1h-benzo[a]quinolizin-2-yl] (2s)-2-amino-3-methylbutanoate Chemical compound C1CN2C[C@@H](CC(C)C)[C@H](OC(=O)[C@@H](N)C(C)C)C[C@@H]2C2=C1C=C(OC)C(OC)=C2 GEJDGVNQKABXKG-CFKGEZKQSA-N 0.000 title abstract 2
- 238000009472 formulation Methods 0.000 title abstract 2
- 229950006411 valbenazine Drugs 0.000 title abstract 2
- 238000000034 method Methods 0.000 title 1
- HQKMJHAJHXVSDF-UHFFFAOYSA-L magnesium stearate Chemical compound [Mg+2].CCCCCCCCCCCCCCCCCC([O-])=O.CCCCCCCCCCCCCCCCCC([O-])=O HQKMJHAJHXVSDF-UHFFFAOYSA-L 0.000 abstract 2
- 239000008194 pharmaceutical composition Substances 0.000 abstract 2
- 239000007787 solid Substances 0.000 abstract 2
- SERLAGPUMNYUCK-DCUALPFSSA-N 1-O-alpha-D-glucopyranosyl-D-mannitol Chemical compound OC[C@@H](O)[C@@H](O)[C@H](O)[C@H](O)CO[C@H]1O[C@H](CO)[C@@H](O)[C@H](O)[C@H]1O SERLAGPUMNYUCK-DCUALPFSSA-N 0.000 abstract 1
- GUBGYTABKSRVRQ-UHFFFAOYSA-N 2-(hydroxymethyl)-6-[4,5,6-trihydroxy-2-(hydroxymethyl)oxan-3-yl]oxyoxane-3,4,5-triol Chemical compound OCC1OC(OC2C(O)C(O)C(O)OC2CO)C(O)C(O)C1O GUBGYTABKSRVRQ-UHFFFAOYSA-N 0.000 abstract 1
- 229920002261 Corn starch Polymers 0.000 abstract 1
- 235000019759 Maize starch Nutrition 0.000 abstract 1
- 239000003814 drug Substances 0.000 abstract 1
- 229940079593 drug Drugs 0.000 abstract 1
- 239000001866 hydroxypropyl methyl cellulose Substances 0.000 abstract 1
- 235000010979 hydroxypropyl methyl cellulose Nutrition 0.000 abstract 1
- 229920003088 hydroxypropyl methyl cellulose Polymers 0.000 abstract 1
- UFVKGYZPFZQRLF-UHFFFAOYSA-N hydroxypropyl methyl cellulose Chemical compound OC1C(O)C(OC)OC(CO)C1OC1C(O)C(O)C(OC2C(C(O)C(OC3C(C(O)C(O)C(CO)O3)O)C(CO)O2)O)C(CO)O1 UFVKGYZPFZQRLF-UHFFFAOYSA-N 0.000 abstract 1
- 239000000905 isomalt Substances 0.000 abstract 1
- 235000010439 isomalt Nutrition 0.000 abstract 1
- HPIGCVXMBGOWTF-UHFFFAOYSA-N isomaltol Natural products CC(=O)C=1OC=CC=1O HPIGCVXMBGOWTF-UHFFFAOYSA-N 0.000 abstract 1
- 235000019359 magnesium stearate Nutrition 0.000 abstract 1
- 150000003839 salts Chemical class 0.000 abstract 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4866—Organic macromolecular compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K31/00—Medicinal preparations containing organic active ingredients
- A61K31/33—Heterocyclic compounds
- A61K31/395—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins
- A61K31/435—Heterocyclic compounds having nitrogen as a ring hetero atom, e.g. guanethidine or rifamycins having six-membered rings with one nitrogen as the only ring hetero atom
- A61K31/47—Quinolines; Isoquinolines
- A61K31/4738—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems
- A61K31/4745—Quinolines; Isoquinolines ortho- or peri-condensed with heterocyclic ring systems condensed with ring systems having nitrogen as a ring hetero atom, e.g. phenantrolines
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/08—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing oxygen, e.g. ethers, acetals, ketones, quinones, aldehydes, peroxides
- A61K47/12—Carboxylic acids; Salts or anhydrides thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/30—Macromolecular organic or inorganic compounds, e.g. inorganic polyphosphates
- A61K47/36—Polysaccharides; Derivatives thereof, e.g. gums, starch, alginate, dextrin, hyaluronic acid, chitosan, inulin, agar or pectin
- A61K47/38—Cellulose; Derivatives thereof
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0053—Mouth and digestive tract, i.e. intraoral and peroral administration
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/48—Preparations in capsules, e.g. of gelatin, of chocolate
- A61K9/4841—Filling excipients; Inactive ingredients
- A61K9/4858—Organic compounds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P25/00—Drugs for disorders of the nervous system
Abstract
Solid pharmaceutical compositions with high drug loading are provided. A formulation useful for the solid pharmaceutical composition includes valbenazine, or a pharmaceutically acceptable salt thereof, silicified microcrystalline cellulose, isomalt, hydroxypropyl methylcellulose, partially pregelatinized maize starch, and magnesium stearate.
Applications Claiming Priority (5)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US201762561629P | 2017-09-21 | 2017-09-21 | |
US62/561,629 | 2017-09-21 | ||
US201762564951P | 2017-09-28 | 2017-09-28 | |
US62/564,951 | 2017-09-28 | ||
PCT/US2018/051579 WO2019060322A2 (en) | 2017-09-21 | 2018-09-18 | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
Publications (1)
Publication Number | Publication Date |
---|---|
AU2018335259A1 true AU2018335259A1 (en) | 2020-04-09 |
Family
ID=63794661
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
AU2018335259A Pending AU2018335259A1 (en) | 2017-09-21 | 2018-09-18 | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
Country Status (12)
Country | Link |
---|---|
US (3) | US20200276184A1 (en) |
EP (1) | EP3684333A2 (en) |
JP (1) | JP7250006B2 (en) |
CN (1) | CN111372567B (en) |
AU (1) | AU2018335259A1 (en) |
BR (1) | BR112020005373A2 (en) |
CA (1) | CA3076000A1 (en) |
IL (3) | IL309802A (en) |
MA (1) | MA50175A (en) |
MX (1) | MX2020002841A (en) |
TW (1) | TW201919622A (en) |
WO (1) | WO2019060322A2 (en) |
Families Citing this family (12)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN108473489B (en) | 2015-10-30 | 2022-09-02 | 纽罗克里生物科学有限公司 | VALBENAZINE salts and polymorphs thereof |
LT3394057T (en) | 2015-12-23 | 2022-06-27 | Neurocrine Biosciences, Inc. | Synthetic method for preparation of (s)-(2r,3r,11br)-3-isobutyl-9,10-dimethoxy-2,3,4,6,7,11b-hexahydro-1h-pyrido[2,1,-a]lsoquinolin-2-yl 2-amino-3-methylbutanoate di(4-methylbenzenesulfonate) |
SG11201906883SA (en) | 2017-01-27 | 2019-08-27 | Neurocrine Biosciences Inc | Methods for the administration of certain vmat2 inhibitors |
AU2018335259A1 (en) | 2017-09-21 | 2020-04-09 | Neurocrine Biosciences, Inc. | High dosage valbenazine formulation and compositions, methods, and kits related thereto |
CA3077149A1 (en) | 2017-10-10 | 2019-04-18 | Neurocrine Biosciences, Inc. | Methods for the administration of (s)-2-amino-3-methyl-butyric acid (2r,3r,11br)-3-isobutyl-9,10-dimethoxy-1,3,4,6,7,11b-hexahydro-2h-pyrido[2,1-a]isoquinolin-2yl ester and salts thereof |
US10993941B2 (en) | 2017-10-10 | 2021-05-04 | Neurocrine Biosciences, Inc. | Methods for the administration of certain VMAT2 inhibitors |
CN110621674B (en) | 2017-12-26 | 2022-03-29 | 苏州科睿思制药有限公司 | Valbenzine di-p-toluenesulfonate crystal form and preparation method and application thereof |
SG11202011544UA (en) | 2018-06-14 | 2020-12-30 | Neurocrine Biosciences Inc | Vmat2 inhibitor compounds, compositions, and methods relating thereto |
KR20210044817A (en) | 2018-08-15 | 2021-04-23 | 뉴로크린 바이오사이언시즈 인코퍼레이티드 | Methods of Administration of Specific VMAT2 Inhibitors |
US10940141B1 (en) | 2019-08-23 | 2021-03-09 | Neurocrine Biosciences, Inc. | Methods for the administration of certain VMAT2 inhibitors |
JP2022547990A (en) | 2019-09-13 | 2022-11-16 | ニューロクライン バイオサイエンシーズ,インコーポレイテッド | Method for Synthesis of Valbenazine |
EP4330255A1 (en) | 2021-04-26 | 2024-03-06 | Neurocrine Biosciences, Inc. | Processes for the synthesis of valbenazine |
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2018
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IL301770A (en) | 2023-05-01 |
US11026939B2 (en) | 2021-06-08 |
MA50175A (en) | 2021-04-21 |
JP7250006B2 (en) | 2023-03-31 |
IL273300B1 (en) | 2024-02-01 |
EP3684333A2 (en) | 2020-07-29 |
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